Attach A-3_Tobacco Item Spreadsheet

Attach A-3_Tobacco Item Spreadsheet.xlsx

Questionnaire Cognitive Interviewing and Pretesting (NCI)

Attach A-3_Tobacco Item Spreadsheet

OMB: 0925-0589

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Overview

A. Construct Overview by Survey
B. HINTS-FDA Items for Testing

Sheet 1: A. Construct Overview by Survey

Comparison of broad HINTS-FDA constructs to those found on other Federal surveys

Survey

Years Conducted

Sample size

Mode

Study Design

Primary purpose

HINTS communication core

Tobacco use phenotypes

Menthol

Perceptions of different themes of (mock) tobacco ads / Tobacco product claims and labels

Tobacco Message Exposure Source/Frequency/Reaction

Product constituents

Risk perceptions about new tobacco products

Attitudes and beliefs about product regulation (safety)

TUS-CPS

1992-1993, 1995-
1996, 1998-1999,
2000, 2001-2002,
2003, 2006-2007, and 2010-11

~ 240,000

70% by telephone and 30% in
person

Cross-sectional

NCI-sponsored survey of tobacco use administered as part of the US Census Bureau's Current Population Survey

Yes

NHIS

Annually, since 1957

~ 27,000

In-person

Cross-sectional

NHIS data on a broad range of health topics are collected through personal household interviews. The U.S. Census Bureau is the data collection agent.

Yes

BRFSS

Annually, since 1984

More than 350,000 adults are interviewed each year

Telephone

Cross-sectional

NHIS data on a broad range of health topics are collected through personal household interviews. The U.S. Census Bureau is the data collection agent.

Yes

ATS-CDC / NATS

33 CDC supported ATS's were conducted in 19 states from 2003-
2007; 2009 - Present NATS (yearly)

~75,000

RDD design telephone survey (Final questionnaires were developed by each state)

Cross-sectional

NATS seeks to determine tobacco use prevalence and the factors promoting and impeding tobacco use among adults in a nationally representative sample of adults and will provide time-critical monitoring data needed to evaluate the effectiveness of new regulatory authorities given to FDA under the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act)

Yes

NSDUH

Periodically since
1972 and annually since 1991

Approximately 70,000 individuals, age 12 and older

In-person interviews with sample persons

Cross-sectional

The NSDUH provides data on prevalence and correlates of substance use, serious mental illness, related problems, and treatment in the civilian population aged 12 or older in the U.S.

Yes

NYTS

1999, 2000, 2002,
2004, 2006, and 2009

22,679 in 2009

In school, self- administered survey via pencil

Cross-sectional

The NYTS provides prevalence estimates for selected tobacco use behaviors among middle
school and high school students regarding tobacco.

Yes

YRBS

Every odd year since
1991

~15,000

School-based, self-administered questionnaire

Cross-sectional

The Youth Risk Behavior Surveillance System (YRBSS) monitors priority health-risk behaviors and the prevalence of obesity and asthma among youth and young adults.

Yes

MTF

Annually since 1975

~50,000

School-based, self-administered questionnaire
with mailed follow up

Cross-sectional with annual follow-up mailed questionnaires among a sample of each graduating class.

MTF is an ongoing study of the behaviors, attitudes, and values of American secondary school students, college students, and young adults.

Yes

YTS

Periodically since
1999 in participating states

~27,000

School-based survey of students in grades 6 through 12.

Cross-sectional

The YTS is intended to enhance the capacity of agencies and organizations to design, implement, and evaluate tobacco prevention and control programs.

Yes

NHANES

A series of surveys since 1959; 1999-
2000, 2001-02, 2003-
04, 2005-06, 2007-08

~5,000

In-person inteviews and physician examinations

Cross-sectional

NHANES findings are used to determine the prevalence of major diseases and risk factors for diseases, assess nutritional status and its association with health promotion and
disease prevention.

Yes

PATH

To begin in 2013

~60,000

In-person

Longitudinal

PATH findings will be used to inform FDA's regulatory authority over tobacco products.

Yes

HINTS

2003, 2005, 2007, yearly from 2011-2014 (in progress)

~3,500

Mailed survey; additional RDD telephone sample in 2005

Cross-sectional

NCI-sponsored survey that collects nationally representative data routinely about adults’ access to and use of health information in the broad public communication environment. The FDA Cycle will collect data relevant to the Family Smoking Prevention and Tobacco Control Act. Data will be used to inform FDA’s tobacco prevention campaigns and tobacco control outreach and education.

Yes

Sheet 2: B. HINTS-FDA Items for Testing

Items for Cognitive Testing

Item number

TUS-CPS

NHIS

BRFSS

NATS

NSDUH

NYTS

YRBS

MTF

YTS

NHANES

PATH

Justification for Potential Inclusion in Final Instrument

What kinds of information on tobacco products have you ever looked for from any source?

A17

Not included

This question is unique to the HINTS program and is part of the HINTS “communication core,” which allows investigators to assess how public information exposure and information seeking influence health knowledge, attitudes, and behavior at the population level. This question has been asked in at least one iteration of HINTS since 2003, and will be integral to informing FDA’s tobacco prevention campaigns and tobacco outreach and education, by allowing investigators to assess how respondents' tobacco-specific information seeking is associated with their tobacco use behaviors, knowledge, etc.

Overall, how confident are you that you could get advice or health information about tobacco products if you needed it?

A19

Not included

This question is unique to the HINTS program and is part of the HINTS “communication core,” which allows investigators to assess how public information exposure and information seeking influence health knowledge, attitudes, and behavior at the population level. This question has been asked in at least one iteration of HINTS since 2003, and will be integral to informing FDA’s tobacco prevention campaigns and tobacco outreach and education, by allowing investigators to assess how respondents' self-efficacy about tobacco-specific information seeking is associated with their tobacco use behaviors, knowledge, etc.

Tobacco use phenotypes

Which of the following tobacco products have you ever heard of? (Hookah or water pipe filled with tobacco; Electronic Cigarettes [such as blu, NJOY, or Ruyan]; Pipe filled with tobacco; "Roll your own" cigarettes; Snus [such as Camel, Marlboro, Skoal, or Swedish Match snus]

C18

Not included

Similar"Before today, had you ever heard of electronic cigarettes or e‐cigarettes?"

Not included

Included

Not included

Included (as multiple items)

This question assesses awareness of “new and emerging” tobacco products that are of interest to CTP. This item will be used to get a population-level scan of awareness, but more importantly awareness of these products will be examined in the context of exposure to tobacco-relevant messaging through various media channels, risk perceptions of tobacco products and trust in various information sources. This information will be used by CTP to inform its regulatory authority over certain traditional tobacco products and its communication campaigns and education outreach efforts.

Addiction

How many containers of smokeless tobacco (including containers of snus) per week do you use?

C17

Not included

Indirect "About how many days does it take you to use up this size container [of smokeless tobacco product]"

This item is derived from the Fagerstrom Test for Nicotine dependence – Heaviness of Smoking Index (Smokeless Tobacco), a measure of physical dependence to nicotine and heaviness of use of smokeless tobacco products. It will be used to classify current tobacco users’ level of dependence and heaviness of use to segment respondents and examine group differences in beliefs, information seeking, and media exposure. This information will be used by CTP to inform its regulatory authority over tobacco products with specific respect to nicotine as well as communication campaigns and education outreach efforts.

On a scale of one to five, where one is strongly disagree, and five is strongly agree, please indicate how much you agree or disagree with the following statements 1. Nicotine is the main substance in tobacco that makes people want to smoke. 2. The nicotine in cigarettes is the substance that causes most of the cancer caused by smoking 3. Addiction to nicotine is something that I am concerned about

C26

Not included

Included (1 only)

These items assess beliefs about nicotine, which are critical to CTP’s regulatory authority over levels of nicotine in tobacco products. These items will serve as baseline measures of population-level beliefs about nicotine which will inform CTP policies and associated communication efforts. In addition the association between these items, tobacco use, risk perceptions and beliefs will be examined in more detail to inform CTP’s efforts.

Overall, how addictive do you believe each of the following is? (Not at all addictive, Moderately addictive, Very Addictive): Cigarette smoking; Cigar smoking; Smokeless tobacco use; Electronic cigarettes; Smoking tobacco in a hookah; Smoking “roll your own” cigarettes; Pipe filled with tobacco

C27

Not included

Included

Not included

Perceptions of different themes of (mock) tobacco ads / Tobacco product claims and labels

Compared to a typical cigarette, would you think that a cigarette advertised as “TSNA-Free” would be…[Much more harmful--much less harmful]

F12

Not included

The three items in this section examine perceptions of tobacco products claims. This information is critical to CTP’s regulatory authority which includes review of industry studies and applications for modified risk tobacco products through understanding consumer's beliefs, perceptions and evalautions of tobacco product claims.

Compared to a typical cigarette, would you think that a cigarette advertised as “TSNA-Free” would be… [Much more addictive--Much less addictive]

F13

Not included

The items in this section examine perceptions of tobacco modified risk claims. This information is critical to CTP’s regulatory authority which includes review of industry studies and applications for modified risk tobacco products through understanding consumer's beliefs, perceptions and evalautions of tobacco product claims as well as enforcement actions against companies that make such claims with a marketing order from FDA.

If a tobacco product made a claim that it was less harmful to health than other tobacco products, how likely would you be to use that product?

E33

Not included

If a tobacco product made a claim that it was less addictive than other tobacco products, how likely would you be to use that product?

E34

Not included

Which cigarette do you think is more harmful to your health?

F2, F6

Not included

Which cigarette do you think is more addictive?

F3, F7

Not included

How believable is it that Cigarette B shown above on the right could be “Low nicotine”/"TSNA Free"?

F4, F8, F11, F14

Not included

Compared to a typical cigarette, would you think that a cigarette [pictured above/advertised as “low nicotine”/advertised as “TSNA Free”] would be…Much more harmful to your health than a typical cigarette; Slightly more harmful to your health than a typical cigarette; Equally harmful to your health as a typical cigarette; Slightly less harmful to your health as a typical cigarette; Much less harmful to your health than a typical cigarette.

F1, F5, F9, F10

Not included

Tobacco Message Exposure Source/Frequency/Reaction

In the past 30 days, how often have you seen, heard, or read a message about [Health effects of tobacco use on tobacco users / Prevention of tobacco use among youth]/ Health effects of harmful chemicals in tobacco products from each of the following sources?: Newspaper (online format), Newspaper (print format), Alternative newspaper (print format), Television, Magazine, Radio, Internet (social media), Internet (company/org website), Internet (health-specific website), Internet (government website), Billboard, Public transportation, Coupon/Mailings, Community event, Point of sale (such as at or inside convenience stores, drug stores or supermarkets)

D1, D3, D7

Not included

Similar "In the past 30 days, have you noticed any health warnings on tobacco advertisements in stores
where tobacco products are sold?"

Not included

Similar "When you read newspapers or magazines / When you are using the Internet / When you go to a convenience store, supermarket, or gas station, how often do you see ads or promotions for cigarettes or other tobacco products?; how often did you see any ads or promotions for cigarettes or other tobacco products that were outdoors on a billboard or could be seen from outside a store? "

Not included

Similar "During the past 30 days, have you seen or heard commercials on TV, the Internet, or on the radio about the dangers of cigarette smoking"; "When you are using the Internet, how often do you see ads for tobacco products?"

Not included

Similar "Thinking about everything that happens around you, in the last 6 months -- since [6 month anchor] -- how often have you noticed things that promote tobacco? " (individual questions for Point of sale and email)

This question assesses both the types and frequency of tobacco messaging that people are exposed to, as well as the sources from which people receive exposure to both pro- and anti-tobacco messaging. It is much more detailed than similar questions found on other surveys, and its level of detail is consistent with the objectives of HINTS, as the government's primary survey for assessing communication-related constructs. Assessing this level of tobacco message exposure will help to inform CTP's regulatory authority and activities, particularly around campaign planning and outreach and education.

Product constituents

Where have you seen a list of the chemicals that are in tobacco products?

Not included

This item assesses source of exposure to the list of constituents. Information from this item will help CTP target communication and education efforts surrounding the list of constituents as well as monitor exposure among different populations through various media channels.

How interested would you be in seeing a list of chemicals in tobacco products listed by each brand?

Not included

This item assesses interest to look for the list of constituents. Information from this item will help CTP target communication and education efforts surrounding the list of constituents.

Why would you be interested in seeing that list?

Not included

This item assesses perceived content of the list to help CTP target communication and education efforts surrounding the list of constituents.

Why would you not be interested in seeing that list?

E10

Not included

This item assesses perceived content of the list and barriers to its effective communication to help CTP target communication and education efforts surrounding the list of constituents.

If you haven’t seen a public list of the chemicals in tobacco products, where do you think you would be able to find that list?

Not included

This item assesses public perception of the availability of the list of constituents to help CTP target communication and education efforts surrounding the list of constituents.

As far as you know, does anyone review tobacco products before they are marketed to consumers?

E14

Not included

This item assesses knowledge of messages that represent key communication objectives of the list of constituents and the surrounding communication and education efforts. These knowledge items will be used to examine impact of the list and communication efforts, target future communication efforts to rectify misunderstanding, as well as to examine differences in knowledge by demographic, tobacco phenotype, exposure to tobacco messages in media, information seeking and other constructs.

As far as you know, does anyone review statements that tobacco companies make about the contents/chemicals or health effects of their products before they are marketed to consumers?

E15

Not included

Do you believe that tobacco products are tested for harmful chemicals?

E16

Not included

How unbiased [fair\impartial\biased] is each of the following to review tobacco products?

E19

Not included

This item assesses perceptions of the impartiality of various organizations which ay be used to convey information about the health risk of tobacco products and may be influenced by exposure to messages in the media.

Who tests tobacco products for harmful chemicals and reports the amounts to FDA?

E17

Not included

The next few questions ask about the priorities of the government to improve people’s health. Please state for each item, whether it should be a high priority, medium priority, low priority, or if the government should not address this issue. a. Promoting health education programs; b. Improving people’s knowledge of health c. Encouraging people to quit smoking through willpower d. Providing support like nicotine patches to help people quit smoking e. Protecting children from tobacco companies advertising and marketing f. Encouraging people to seek counseling to quit smoking

E20

Not included

This item is a modified version of one that has appeared in a small number of non-Governmental surveys on health communication. This item assesses perceptions of priorities for the government by the public, with respect to regulation of tobacco, and will provide information to CTP’s Office of Health Communication and Education about the positioning CTP and FDA in its education efforts. In addition, this item will be used to examine differences in exposure to tobacco messages, and attitudes and beliefs about tobacco.

Attitudes and beliefs about product regulation

How qualified is each of the following to review tobacco products? CDC, FTC, FDA, independent groups, NIH, Surgeon General, Tobacco industry, USBCP

E18

Not included

This question is unique to the HINTS program and assess perceptions of FDA cigarette regulation. This item will allow investigators to assess perceptions of the FDA in the context of other items such as those related to health communication, tobacco behavior, risk perceptions, and knoweldge. This question has never been asked in HINTS or any other national survey. This item is important because understanding attitudes towards the FDA could influence other important factors including risk perceptions about tobacco products. This item is integral to informing FDA’s regulatory authority and activities by allowing investigators to assess how attitudes towards the FDA are associated with health communication, tobacco use behaviors, perceptions, knowledge, etc, an dusing that information to inform how FDA positions itself within the tobacco control space as well as in its public-facing media campaigns and education outreach efforts.

In general, how much would you trust information about the health effects of using tobacco or information about stopping tobacco use from each of the following?
• A doctor
• Family or friends
• Government health agencies (e.g., the Food and Drug Administration (FDA), National Institutes of Health (NIH) or Centers for Disease Control and Prevention (CDC)
• Health organizations or groups (such as the American Cancer Society, American Lung Association or others)
• Charitable organizations
• Religious organizations and leaders

A20

Not included

This question is unique to the HINTS program and assesses trust in different sources about tobacco. This allows investigators to assess how public information exposure and information seeking influence health knowledge, attitudes, and behavior at the population level. A similar item is contained in the HINTS "communication core", however this item is specific to information about tobacco. This item will be integral to informing FDA’s tobacco prevention campaigns and tobacco outreach and education. By allowing investigators to assess how respondents' trust in tobacco information sources is associated with their tobacco use behaviors, knowledge, etc., we will gain a better understanding of outlets that may be best used to reach particular populations. Trust questions are particularly important for planning campaigns and outreach efforts.

Household Tobacco Use

Do you live in the same household with someone who uses tobacco products?
How many people in your household use tobacco products?

I19, I20

Not included

Similar "66. Does anyone who lives with you now…? (CHECK ALL THAT APPLY)."

Not included

Similar "Does anyone who lives with you now smoke cigarettes?"/ "Does anyone who lives with you now use chewing tobacco, snuff, or dip?"

Similar "How many people who live here smoke cigarettes, cigars, little cigars, pipes, water pipes, hookah, or any other tobacco product?"

Similar "Does anyone who lives with you now smoke cigarettes?"/ "Does anyone who lives with you now use chewing tobacco, snuff, or dip?"

These items assess potential social norms about tobacco use, specifically examining use of tobacco products by someone else in the same household, a reliable predictor of tobacco use. This information will be used by CTP to inform its communication campaigns and education outreach efforts.

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